MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR; STERILE TECHNOLOGY

Model Number US751

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Investigation on-going.

Event Description

It was reported that there was an issue with the round filters.While opening an instrument set prior to surgery, the filter was noted to be a lighter color than the others.The staff was concerned about sterility of the small hand tray and possible contamination of the sterile field; another set was used instead.Additional information was not available.

Manufacturer Narrative

Manufacturing site evaluation: manufacturer received no samples, the lot number was not provided, a review of the manufacturing batch record could not be completed nor could product retains be reviewed.A complaint review was performed and there are no other confirmed complaints for the reported issue.Given the manufacturing batch record and product retains could not be reviewed, nor were there photos or returned product provided, crosstex was unable to perform a targeted investigation.As such, no additional corrective action will be taken at this time other than to continue to monitor the complaint database for any reoccurrence.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8588744
• MDR Text Key: 144966440
• Report Number: 2916714-2019-00012
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US751
• Device Catalogue Number: US751
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/07/2019
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSTRUMENT CONTAINER